Natural Products Insider

JUL-AUG 2019

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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32 INSIDER July /August 2019 Product safety is a critical underpinning t o the introduction and subsequent thriving of consumer products in the marketplace. For dietary supplements, ensuring product safety is not solely a premarket concern, but rather one that spans the entire product life cycle. With ever-evolving science, technology and regulatory requirements, as well as shifts in retailer and consumer expectations, responsible manufacturers should have a strong grasp of the baseline regulatory requirements for safety. However, a comprehensive approach composed of best practices can help ensure overall product safety on an ongoing basis. At the beginning of the product life cycle, during the premarket safety assessment, much of the emphasis is on the individual ingredient(s). Whether old or new, each active ingredient in a formulation is carefully assessed for safety under the product's intended conditions of use. Ideally, this is accomplished through a combination of reviewing the literature and gathering information from ingredient suppliers and the manufacturer's ingredient-testing efforts. Properly characterized ingredients assessed for safety can be incorporated into a product formulation. Nevertheless, brands must still implement safety measures. Strict adherence to cGMPs (current good manufacturing practices) is critical while the product is manufactured, packaged and shipped (usually to a warehouse) for holding until it goes to a retail shelf or directly to the consumer. Once the products ships, the handoff to postmarket surveillance—commonly known in the industry as mandatory adverse event collection and reporting—occurs. While related, these two approaches are different. Adverse event reporting refers to the specifi c requirements called for in the 2006 Dietary Supplement and Nonprescription Drug Consumer Protection Act. Postmarket surveillance is a level of surveillance and sophistication well above the basic requirements of mandatory adverse event reporting, which involves a prescriptive process of receiving, documenting, tabulating and submitting adverse event data. A postmarket surveillance approach allows a manufacturer to establish comprehensive product safety profi les, which is particularly advantageous for companies with multiple products and/or global distribution. Analysis of this information can help a manufacturer determine if, and how, its product may have been causally involved in an adverse event and equip the fi rm to defend itself appropriately against allegations of harm, many of which are based on mere associations with a reported adverse event (J Med Toxicol. 2017 Sep;13[3]:227-237). The safety profi le of a product cannot be truly evaluated or known until it enters the market. At that point, a picture can be developed that refl ects how the product is used, how safe complex ingredients and formulas are as consumers use them, and whether products are used alone or in combination with other products or even medications. Conversely, customer usage and experience trends identifi ed through postmarket surveillance can be used to inform modifi cations to product directions and formulations and even future product innovation. Brands can learn which types of ingredients to avoid, and which combinations and conditions of use are best suited for consumers with an integrated 360-degree approach to safety. As products become more complex, consumers' use becomes more varied, regulations become stricter, and threats of litigation and brand reputation consequences loom, it behooves manufacturers to evolve their approach to safety from one that is strictly adhering to the letter of the law, to one that examines and ensures safety throughout the product life cycle. Andrew Shao, Ph.D., is the interim senio r vice president, scientifi c and regulatory affairs, of the Council for Responsible Nutrition (CRN,, a trade association for the dietary supplement and functional food industry. Supplement Safety Considerations for a 360-Degree Approach to Safety: Ensuring Trust and Confidence in Supplements by Andrew Shao, Ph.D. ON-DEMAND WEBINAR CO-SPONSORED BY: To register, visit A 360° Approach to Supplement Safety: Implications for Product Innovation and NDI Compliance Premium Series W E B I N A R

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